Tools for Running a Clinical Trial Internally

Tools for running a clinical trial internally: steps, common blockers, and tool options. EDC, eConsent, ePRO with 21 CFR Part 11–aligned controls.

21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required

Overview

Tools for Running a Clinical Trial Internally

Tools for running a clinical trial internally include one platform for EDC, eConsent, ePRO, and enrollment—so you can build and operate the study in-house with 21 CFR Part 11–aligned controls. Quick answer: use software that supports sponsor- or site-led build and operation. Steps: define protocol and CRF requirements; choose one platform for consent and data capture; build study and run validation/UAT if regulated; launch and operate. Common blockers: vendor-only build, long implementation. Tool options: look for study builder, integrated eConsent and ePRO, documentation for sponsor validation. Capture fit: one platform for EDC, eConsent, ePRO; study builder; documentation for sponsor validation (Enterprise).

Quick answer and steps

Running a trial internally means you need one platform for consent and data capture that you can build and operate—with full audit trail and 21 CFR Part 11–aligned controls. Steps include defining requirements, choosing software, building the study, and launching.

Steps/process

  • Define protocol and CRF requirements
  • Choose one platform for eConsent, EDC, ePRO, and enrollment
  • Build study using study builder; run validation/UAT if regulated
  • Launch and operate; amend when your process allows
  • Documentation to support sponsor validation when required (Enterprise)

Common blockers

  • Software that requires vendor-led build and operation
  • Long implementation and dependency on vendor for build
  • Need for one platform that sponsor or site can build and run
  • Capture: study builder; support for internal operation

Tool options and Capture fit

  • One platform for EDC, eConsent, ePRO, and enrollment; study builder for internal build and operation
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore workflow or book a demo

Related

Clinical trial software without CROSoftware to manage a clinical trialFeatures

FAQ

Questions we hear a lot

What tools do I need to run a clinical trial internally?
You need one platform for EDC, eConsent, ePRO, and enrollment that you can build and operate. Look for study builder and documentation for sponsor validation. Capture includes these; explore workflow or book a demo.
Is Capture 21 CFR Part 11–aligned?
Yes. Capture is designed with 21 CFR Part 11–aligned controls and HIPAA-aligned security. We provide documentation to support sponsor validation when required (Enterprise).

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